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CompletedNCT03091348Updated Oct 8, 2019Results posted

Subcutaneous vs. Intramuscular Testosterone

A Phase 4 interventional study of Testosterone in Testosterone Deficiency and Hypogonadism, Male, sponsored by Men's Health Boston. Completed at 1 site in United States. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-10-08.

Sponsored by Men's Health Boston · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
Male
01

Study summary

In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. The primary objective of this study is to measure testosterone concentration in men after these two treatment routes and determine if there are any significant differences due to modes of administration. Endpoints will include total serum testosterone and calculated free testosterone. A questionnaire will also be administered to assess overall patient experience with each route of administration.

Read the detailed description

Subjects planning to initiate testosterone treatment via injection at MHB will be consented into the study. Upon enrollment in the study, the randomization will be completed for each subject.

Blood collection will occur before each injection. Subjects will rate pain on the Likert scale following each injection. After treatment with the first mode of T administration (SQ or IM depending on randomization), subjects will come in for blood draws 3 days and 7 days following the injection. Two weeks after the initial injection, subjects will come in for treatment with the second mode of T administration (SQ or IM depending on randomization). Subjects will come in for blood draws 3 days and 7 days following the second injection. Two weeks after the second injection, subjects will complete an end of study assessment with an Investigator and will complete a survey assessing their satisfaction with treatment. Subjects will likely continue testosterone therapy at Men's Health Boston after completion of the study.

02

Conditions studied

  • Testosterone Deficiency
  • Hypogonadism, Male

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03

In context

Eunuchism

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's enrollment of 4 is below the median of 60 across 55 interventional studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Men's Health Boston is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to read, write, and understand English
  • Age greater than or equal to 18
  • Diagnosed with testosterone deficiency
  • Pre-enrollment testosterone concentration of less than 350 ng/dL
  • Planning to initiate testosterone treatment at MHB
  • Willing to be followed at MHB for at least one month
  • Willing to provide for this study

Exclusion criteria

Exclusion Criteria:

  • Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks
  • American Urological Association Prostate Symptom score of 15 or greater or significant prostatic symptoms
  • History of carcinoma, tumors or induration of the prostate or the male mammary gland, including suspicion thereof
  • Pre-enrollment serum PSA more than 4 ng/ml
  • Serious psychiatric disease or uncontrolled medical illness, as suspected from the history or clinical examination
  • Used any sex hormones or steroidal anabolic drug supplements within 28 days before pre-enrollment testosterone collection or at any time throughout the study
  • Incapable of giving or complying with the protocol
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    SQ - IM

    Subcutaneous testosterone injection followed by intramuscular testosterone injection

    Drug: Testosterone

  • Experimental
    IM - SQ

    Intramuscular testosterone injection followed by subcutaneous testosterone injection

    Drug: Testosterone

Interventions

  • DrugTestosterone

    Testosterone cypionate injection

    Also known as: Testosterone cypionate, Testosterone injection

06

What researchers measure

Primary outcomes

  1. Change in Levels of Serum Total Testosterone Concentration

    Blood samples measured by Beckman assays and equipment.

    Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

  2. Change in Levels of Serum Calculated Free T Concentration

    Blood samples measured by Beckman assays and equipment.

    Time frame: "Last visit ( Visit 7)"

Secondary outcomes

  1. Change in Levels of Serum Estradiol

    Blood samples measured by Beckman assays and equipment.

    Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

  2. Change in Levels of Serum LH

    Blood samples measured by Beckman assays and equipment.

    Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

  3. Change in Levels of Serum FSH

    Blood samples measured by Beckman assays and equipment.

    Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

  4. Change in Levels of Serum SHBG

    Blood samples measured by Beckman assays and equipment.

    Time frame: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

  5. Change in Level of Serum PSA

    Blood samples measured by Beckman assays and equipment.

    Time frame: "Last visit (Visit 7)"

  6. Change in Levels of Whole Blood Hematocrit

    Blood samples measured by Quest assays and equipment.

    Time frame: "Last visit (Visit 7)"

  7. Change in Low Testosterone Questionnaire Responses

    Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better

    Time frame: after last vist #7

  8. Change in International Prostate Symptom Scores

    Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale 0-35, from Mild to Severe Lower score is better

    Time frame: after last vist #7

07

Results

Posted Sep 25, 2019

Participant flow

Participant flow — Overall Study
MilestoneSQ - IMIM - SQ
Started22
Completed01
Not completed21
Withdrew: Lost to follow-up21

Outcome measures

PrimaryChange in Levels of Serum Total Testosterone Concentration

Blood samples measured by Beckman assays and equipment.

Time frame:
"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Reported as:
Number · ng/dl
Change in Levels of Serum Total Testosterone Concentration
ng/dl"SQ""IM"
visit 2NA1043.6
visit 3NA785.7
visit 4203.5NA
vist 51367.9NA
visit 6980.8NA
visit 7144.7NA
PrimaryChange in Levels of Serum Calculated Free T Concentration

Blood samples measured by Beckman assays and equipment.

Time frame:
"Last visit ( Visit 7)"
Reported as:
Number · ng/dL
Change in Levels of Serum Calculated Free T Concentration
ng/dL"SQ""IM"
Change in Levels of Serum Calculated Free T Concentration0.8414.74
SecondaryChange in Levels of Serum Estradiol

Blood samples measured by Beckman assays and equipment.

Time frame:
"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Reported as:
Number · pg/mL
Change in Levels of Serum Estradiol
pg/mL"SQ""IM"
visit 2NA70.03
visit 3NA52.00
visit 430.06NA
visit 545.12NA
visit 664.74NA
visit 725.99NA
SecondaryChange in Levels of Serum LH

Blood samples measured by Beckman assays and equipment.

Time frame:
"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Reported as:
Number · miu/ml
Change in Levels of Serum LH
miu/ml"SQ""IM"
visit 2NA0.4
visit 3NA0.3
visit 40.2NA
visit 50.04NA
visit 60.1NA
visit 70.4NA
SecondaryChange in Levels of Serum FSH

Blood samples measured by Beckman assays and equipment.

Time frame:
"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Reported as:
Number · miu/ml
Change in Levels of Serum FSH
miu/ml"SQ""IM"
visit 2NA1.3
visit 3NA0.4
visit 40.2NA
visit 50.1NA
visit 60.05NA
visit 70.3NA
SecondaryChange in Levels of Serum SHBG

Blood samples measured by Beckman assays and equipment.

Time frame:
"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Reported as:
Number · nmol/l
Change in Levels of Serum SHBG
nmol/l"SQ""IM"
visit 2NA25.5
visit 3NA22
visit 427.8NA
visit 524.8NA
visit 622.9NA
visit 720.7NA
SecondaryChange in Level of Serum PSA

Blood samples measured by Beckman assays and equipment.

Time frame:
"Last visit (Visit 7)"
Reported as:
Number · ng/mL
Change in Level of Serum PSA
ng/mL"SQ""IM"
Change in Level of Serum PSA0.250.02
SecondaryChange in Levels of Whole Blood Hematocrit

Blood samples measured by Quest assays and equipment.

Time frame:
"Last visit (Visit 7)"
Reported as:
Number · g/dL
Change in Levels of Whole Blood Hematocrit
g/dL"SQ""IM"
Change in Levels of Whole Blood HematocritNA1.9
SecondaryChange in Low Testosterone Questionnaire Responses

Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better

Time frame:
after last vist #7

No measurements were reported for this outcome.

SecondaryChange in International Prostate Symptom Scores

Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale 0-35, from Mild to Severe Lower score is better

Time frame:
after last vist #7

No measurements were reported for this outcome.

Adverse events

Collected over AE were monitored/assessed at each study visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SQ Testosterone0/2 (0%)0/2 (0%)0/2 (0%)
IM Testosterone0/2 (0%)0/2 (0%)0/2 (0%)

Baseline characteristics

Participants analyzed is 0 and 1 due to loss to follow up

Age, Continuous
Age, Continuous(years)SQ-IMIM-SQTotal
Mean—44 ± 044 ± 0
Sex: Female, Male
Sex: Female, Male(Participants)SQ-IMIM-SQTotal
Female000
Male011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SQ-IMIM-SQTotal
American Indian or Alaska Native—00
Asian—00
Native Hawaiian or Other Pacific Islander—00
Black or African American—00
White—11
More than one race—00
Unknown or Not Reported—00
Region of Enrollment
Region of Enrollment(participants)SQ-IMIM-SQTotal
United States—11
Estradiol (E2)
Estradiol (E2)(pg/ml)SQ-IMIM-SQTotal
Number—24.524.5
Human Follicle Stimulating Hormone (hFSH)
Human Follicle Stimulating Hormone (hFSH)(miu/ml)SQ-IMIM-SQTotal
Number—3.53.5
Hemophagocytic lymphohistiocytosis(hLH)
Hemophagocytic lymphohistiocytosis(hLH)(miu/ml)SQ-IMIM-SQTotal
Number—33
Sex hormone binding globulin(SHBG)
Sex hormone binding globulin(SHBG)(nmol/l)SQ-IMIM-SQTotal
Number—27.327.3

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Men's Health Boston
    Chestnut Hill, Massachusetts 02467, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Nov 2017, 2 months.

Results were first posted in Sep 2019, 1 year 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2017
First posted
Mar 27, 2017
StartActual
Aug 29, 2017
Primary completionActual
Nov 21, 2017
CompletionActual
Jan 2, 2018
Results first posted
Sep 25, 2019
Last update
Oct 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03091348
Lead sponsor
Men's Health Boston
Responsible party
Dr. Abraham Morgentaler (Director, Men's Health Boston) — Principal investigator
First posted
Mar 27, 2017
Start date
Aug 29, 2017
Primary completion
Nov 21, 2017
Completion
Jan 2, 2018
Results posted
Sep 25, 2019
Last update
Oct 8, 2019

Study contacts

Abraham Morgentaler, MD
principal investigator · Men's Health Boston, Harvard Medical School

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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